Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Linshom Medical, Inc.
Study ID
NCT06744790
Status
Recruiting
Apply to this trial

Conditions

  • Post Surgical Respiratory Failure
  • Respiratory Complication

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Linshom Continuous Predictive Respiratory Monitoring — DEVICE
    Observational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care.

Study Details

Investigators will enroll 320 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask, and will be on a continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). The enrollment criteria were adapted from a previous study that showed SpO2 values seriously underestimated the severity of post-operative hypoxemia in patients with and without specific risk factors for hypoxemia. Research personnel will screen and ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival to the PACU, each subject will be fitted with oxygen mask containing the Linshom sensor, which will be connected to a Linshom monitor for data collection. A side stream capnography line will be connected to the same face mask and the capnography data will be collected on the Zoe Medical 740 SELECT™ monitor. Additionally, two pulse oximeters will be applied to the same hand (non- NIBP arm), one of which will be connected to a hospital monitor (SoC) and the other to a Zoe Medical 740 SELECT™ monitor. The Linshom and 740 SELECT™ monitors will collect data once every second. Research personnel will then initiate the Linshom CPRM baseline mode and begin recording any clinical intervention (e.g., medications, oxygen delivery change, and stimulation upon detection of changes in patient's condition) that is performed by the PACU staff, paying close attention to, and recording of time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. The CPRM data collection will be performed passively while the patient is monitored via SoC and will not interfere with clinical interventions that may take place during the data collection. Clinical staff in the PACU will be blinded to the Linshom CPRM data as well as pulse oximetry (non-SOC monitor) and capnography data collected.

Key Dates

Start date
Jun 21, 2023
Status verified
Oct 2024
Primary completion
Jun 16, 2025
Completion
Jun 16, 2025

Study Design

Enrollment
320 participants (estimated)

Arms

  • Arm: Post surgical (non-cardiac) PACU patients with anticipated overnight stay.
    In this study investigators will recruit patients that meet the following criteria: Inclusion Criteria: ≥18 years old undergoing non-cardiac surgery Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight Receiving supplemental oxygen via face mask in the PACU On continuous SpO2 saturation monitoring Receiving standard postoperative of care Exclusion Criteria: Requirement for any form of postoperative invasive ventilatory support Patients receiving only local or topical anesthesia Day/outpatient surgery Unable to cooperate with the application of the study device Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation

Primary Outcome Measure

Non-inferiority of Linshom CPRM to pulse oximetry with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur. [ Time Frame: 6-12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201-

Find similar trials in Baltimore, MD

By research site
University of Maryland Medical Center· Baltimore, MD

Related Studies